FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3T VESSEL CANNULAS
K Number: K020768
·
Decision Aug 23, 2002
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
5
Review Days
169
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Basic Information
- Device Name
- 3T VESSEL CANNULAS
- K Number
- K020768
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- 3t Medical Systems, LLC
- Date Received
- March 7, 2002
- Decision Date
- August 23, 2002
- Product Code
- DWF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by 3t Medical Systems, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K072697 | 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES | Dec 20, 2007 | Substantially Equivalent |
| K022287 | 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS | Sep 23, 2002 | Substantially Equivalent |
| K020365 | 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE | May 3, 2002 | Substantially Equivalent |
| K001245 | 3T L. V. CONTROL VALVE | Aug 15, 2001 | Substantially Equivalent |